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A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

Trial Profile

A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Dec 2023

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At a glance

  • Drugs Clonidine (Primary)
  • Indications Stomatitis
  • Focus Therapeutic Use
  • Sponsors BioAlliance Pharma; Onxeo SA; Valerio Therapeutics
  • Most Recent Events

    • 24 Jun 2021 will present its oropharyngeal cancer (OPC) patient population analysis of this trial at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting.This analysis provided the rationale for the design of Phase 2b/3 VOICE trial.
    • 01 Feb 2020 Results published in the International Journal of Radiation Oncology, Biology, Physics
    • 22 Oct 2015 Compliance and patient acceptability results presented at the 57th American Society for Radiation Oncology (ASTRO) Annual Meeting 2015, according to an Onxeo SA media release.
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